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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K260910

510(k) cleared

EndoTool IV Cloud 1.0

Glooko, Inc. · May 1, 2026 · K260910

FDA cleared the EndoTool IV Cloud 1.0 from Glooko, Inc. on May 1, 2026 under K260910, a traditional 510(k). The device falls under product code NDC, Calculator, Drug Dose, regulated at 21 CFR 868.1890 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Mar 19, 2026. The decision came 43 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Glooko, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260910?

K260910 is the FDA 510(k) for EndoTool IV Cloud 1.0, submitted by Glooko, Inc.. FDA's decision date was May 1, 2026, under product code NDC (Calculator, Drug Dose).

Who makes the EndoTool IV Cloud 1.0?

Glooko, Inc., based in Palo Alto, CA, is the applicant of record for K260910.

How long did the K260910 review take?

FDA received the submission on Mar 19, 2026 and issued its decision on May 1, 2026, 43 days later.

← All decisions in May 2026